{"id":9492,"date":"2026-02-16T17:31:59","date_gmt":"2026-02-16T09:31:59","guid":{"rendered":"https:\/\/regask.com\/?p=9492"},"modified":"2026-02-16T17:31:59","modified_gmt":"2026-02-16T09:31:59","slug":"la-tga-de-australia-actualiza-la-guia-sobre-software-de-dispositivos-medicos-con-ia-y-los-requisitos-de-evidencia-de-artg","status":"publish","type":"post","link":"https:\/\/regask.com\/es\/australia-tga-updates-guidance-on-ai-enabled-medical-device-software-and-artg-evidence-requirements\/","title":{"rendered":"La TGA de Australia actualiza la gu\u00eda sobre desarrollo m\u00e9dico con IA\u2026"},"content":{"rendered":"<p>En <strong>5 de febrero de 2026<\/strong>, el <strong>Administraci\u00f3n de Productos Terap\u00e9uticos (TGA)<\/strong> public\u00f3 una gu\u00eda actualizada que aclara c\u00f3mo <strong>software habilitado con inteligencia artificial<\/strong> Est\u00e1 regulado como dispositivo m\u00e9dico en Australia. La actualizaci\u00f3n afecta a las organizaciones que desarrollan, suministran o mantienen software de dispositivos m\u00e9dicos basado en IA y define expectativas m\u00e1s claras para la clasificaci\u00f3n regulatoria, la generaci\u00f3n de evidencia y la gesti\u00f3n del ciclo de vida.<\/p>\n<div class=\"row\"  id=\"row-1373132803\">\n\n\t<div id=\"col-683769130\" class=\"col small-12 large-12\"  >\n\t\t\t\t<div class=\"col-inner\"  >\n\t\t\t\n\t\t\t\n\t<div id=\"gap-89561742\" class=\"gap-element clearfix\" style=\"display:block; height:auto;\">\n\t\t\n<style>\n#gap-89561742 {\n  padding-top: 20px;\n}\n<\/style>\n\t<\/div>\n\t\n<h2>Detalles de la actualizaci\u00f3n<\/h2>\n\t<div id=\"gap-918462105\" class=\"gap-element clearfix\" style=\"display:block; height:auto;\">\n\t\t\n<style>\n#gap-918462105 {\n  padding-top: 15px;\n}\n<\/style>\n\t<\/div>\n\t\n<p>La gu\u00eda actualizada aclara que <strong>El software habilitado con IA se regula como un dispositivo m\u00e9dico en funci\u00f3n de su prop\u00f3sito previsto,<\/strong> Independientemente de la tecnolog\u00eda subyacente o la plataforma de entrega. Software dise\u00f1ado para <strong>diagn\u00f3stico, seguimiento o tratamiento<\/strong> debe estar incluido en el <strong>Registro Australiano de Productos Terap\u00e9uticos (ARTG)<\/strong> antes de que pueda suministrarse en Australia.<\/p>\n<p>La gu\u00eda explica las obligaciones de los fabricantes para gestionar <strong>actualizaciones de software y ampliaci\u00f3n del alcance,<\/strong> destacando que los cambios que alteran el uso o el rendimiento previstos pueden generar la necesidad de <strong>aprobaci\u00f3n regulatoria antes de su lanzamiento.<\/strong> Tambi\u00e9n aborda <strong>uso fuera de etiqueta,<\/strong> indicando que cuando se detecta dicho uso, los fabricantes est\u00e1n obligados a restringirlo o buscar la inclusi\u00f3n de ARTG para la nueva indicaci\u00f3n.<\/p>\n<p>En relaci\u00f3n con la generaci\u00f3n de evidencia, la TGA aclara las expectativas para <strong>datos sint\u00e9ticos,<\/strong> se\u00f1alando que si bien puede utilizarse para complementar la evidencia cl\u00ednica, <strong>No puede reemplazar los datos cl\u00ednicos del mundo real.<\/strong> Cuando se utilizan datos sint\u00e9ticos para la validaci\u00f3n, los fabricantes deben documentar tanto <strong>Justificaci\u00f3n de su uso<\/strong> y el<strong> m\u00e9todos utilizados para generarlo.\u00a0<\/strong><\/p>\n\t\t<\/div>\n\t\t\t\t\n<style>\n#col-683769130 > .col-inner {\n  margin: 0px 0px -20px 0px;\n}\n<\/style>\n\t<\/div>\n\n\t\n\n\t<div id=\"col-2194781\" class=\"col small-12 large-12\"  >\n\t\t\t\t<div class=\"col-inner\"  >\n\t\t\t\n\t\t\t\n<h2>Fecha de entrada en vigor<\/h2>\n\t<div id=\"gap-1826997301\" class=\"gap-element clearfix\" style=\"display:block; height:auto;\">\n\t\t\n<style>\n#gap-1826997301 {\n  padding-top: 15px;\n}\n<\/style>\n\t<\/div>\n\t\n<p>La gu\u00eda actualizada de la TGA sobre el software de dispositivos m\u00e9dicos habilitado con IA se aplica a partir de <strong>5 de febrero de 2026. <\/strong><\/p>\n\t\t<\/div>\n\t\t\t\t\n<style>\n#col-2194781 > .col-inner {\n  margin: 0px 0px -20px 0px;\n}\n<\/style>\n\t<\/div>\n\n\t\n\n\t<div id=\"col-1010535817\" class=\"col small-12 large-12\"  >\n\t\t\t\t<div class=\"col-inner\"  >\n\t\t\t\n\t\t\t\n<h2>Por qu\u00e9 es importante<\/h2>\n\t<div id=\"gap-1154345522\" class=\"gap-element clearfix\" style=\"display:block; height:auto;\">\n\t\t\n<style>\n#gap-1154345522 {\n  padding-top: 15px;\n}\n<\/style>\n\t<\/div>\n\t\n<p>Esta actualizaci\u00f3n proporciona mayor claridad regulatoria sobre c\u00f3mo se eval\u00faa, mantiene y evidencia el software de dispositivos m\u00e9dicos basado en IA a lo largo de su ciclo de vida. Al establecer expectativas m\u00e1s claras en torno a las tecnolog\u00edas de salud digital, la gesti\u00f3n de actualizaciones y los est\u00e1ndares de evidencia, la gu\u00eda promueve una alineaci\u00f3n regulatoria m\u00e1s consistente, a la vez que busca reducir la incertidumbre y la carga innecesaria de cumplimiento para las partes interesadas reguladas.<\/p>\n\t\t<\/div>\n\t\t\t\t\n<style>\n#col-1010535817 > .col-inner {\n  margin: 0px 0px -20px 0px;\n}\n<\/style>\n\t<\/div>\n\n\t\n\n\t<div id=\"col-566947460\" class=\"col small-12 large-12\"  >\n\t\t\t\t<div class=\"col-inner\"  >\n\t\t\t\n\t\t\t\n<h2>Para qui\u00e9n es relevante<\/h2>\n\t<div id=\"gap-812522078\" class=\"gap-element clearfix\" style=\"display:block; height:auto;\">\n\t\t\n<style>\n#gap-812522078 {\n  padding-top: 15px;\n}\n<\/style>\n\t<\/div>\n\t\n<p>La gu\u00eda es relevante para asuntos regulatorios, garant\u00eda de calidad, seguridad del paciente, legales y de cumplimiento, comerciales y de marketing, y equipos de I+D involucrados en el desarrollo y la gesti\u00f3n del ciclo de vida del software de dispositivos m\u00e9dicos basado en IA en Australia.<\/p>\n\t\t<\/div>\n\t\t\t\t\n<style>\n#col-566947460 > .col-inner {\n  margin: 0px 0px -20px 0px;\n}\n<\/style>\n\t<\/div>\n\n\t\n\n\t<div id=\"col-1230963659\" class=\"col small-12 large-12\"  >\n\t\t\t\t<div class=\"col-inner\"  >\n\t\t\t\n\t\t\t\n<h2>Pr\u00f3ximos pasos<\/h2>\n\t<div id=\"gap-227296855\" class=\"gap-element clearfix\" style=\"display:block; height:auto;\">\n\t\t\n<style>\n#gap-227296855 {\n  padding-top: 15px;\n}\n<\/style>\n\t<\/div>\n\t\n<p>Las organizaciones deben revisar los productos de software habilitados para IA actuales y en desarrollo para confirmar la alineaci\u00f3n con los requisitos aclarados. <strong>Criterios de inclusi\u00f3n de ARTG<\/strong> y expectativas de documentaci\u00f3n. Procesos internos para la gesti\u00f3n <strong>actualizaciones de software<\/strong> y <strong>detecci\u00f3n de uso fuera de etiqueta<\/strong> deben evaluarse para garantizar que cumplan con las directrices actualizadas y las estrategias de evidencia deben revisarse cuando sea necesario. <strong>datos sint\u00e9ticos<\/strong> Se utiliza en la validaci\u00f3n.<\/p>\n<p>A medida que las expectativas regulatorias para los dispositivos m\u00e9dicos impulsados por IA contin\u00faan evolucionando, mantenerse a la vanguardia de las actualizaciones de las directrices es fundamental. <strong><a href=\"http:\/\/regask.com\/es\/\">RegASK<\/a> Es una plataforma l\u00edder de inteligencia regulatoria y orquestaci\u00f3n de flujos de trabajo con IA agentic que permite a organizaciones globales en sectores altamente regulados, como productos de consumo y ciencias de la vida, gestionar de forma proactiva entornos regulatorios complejos. Al combinar IA agentic avanzada con expertos en el sector, <a href=\"http:\/\/regask.com\/es\/\">RegASK<\/a><\/strong> <strong>Proporciona informaci\u00f3n predictiva y procesable oportuna y automatizaci\u00f3n de extremo a extremo, agilizando los procesos de cumplimiento, mitigando riesgos y acelerando el acceso al mercado en m\u00e1s de 160 pa\u00edses.<\/strong> <a href=\"http:\/\/regask.com\/es\/\"><strong>M\u00e1s informaci\u00f3n<\/strong><\/a> o <a href=\"https:\/\/regask.com\/es\/\"><strong>Reserve una demostraci\u00f3n ahora.\u00a0<\/strong><\/a><\/p>\n\t\t<\/div>\n\t\t\t\t\n<style>\n#col-1230963659 > .col-inner {\n  margin: 0px 0px -20px 0px;\n}\n<\/style>\n\t<\/div>\n\n\t\n<\/div>\n<div class=\"row\"  id=\"row-648082251\">\n\n\t<div id=\"col-2005019896\" class=\"col small-12 large-12\"  >\n\t\t\t\t<div class=\"col-inner\"  >\n\t\t\t\n\t\t\t\n<div class=\"is-divider divider clearfix\" style=\"margin-top:2em;margin-bottom:2em;max-width:20%;height:1px;background-color:#a5acd9;\"><\/div>\n<h3>Preguntas frecuentes<\/h3>\n\t<div id=\"gap-1639648025\" class=\"gap-element clearfix\" style=\"display:block; height:auto;\">\n\t\t\n<style>\n#gap-1639648025 {\n  padding-top: 10px;\n}\n<\/style>\n\t<\/div>\n\t\n<h4>\u00bfCu\u00e1ndo se regula el software habilitado con IA como dispositivo m\u00e9dico en Australia?<\/h4>\n\t<div id=\"gap-1473303727\" class=\"gap-element clearfix\" style=\"display:block; height:auto;\">\n\t\t\n<style>\n#gap-1473303727 {\n  padding-top: 10px;\n}\n<\/style>\n\t<\/div>\n\t\n<p>El software habilitado con IA se regula como un dispositivo m\u00e9dico cuando su <strong>prop\u00f3sito previsto<\/strong> es para diagn\u00f3stico, seguimiento o tratamiento, independientemente de la tecnolog\u00eda o plataforma utilizada.<\/p>\n\t\t<\/div>\n\t\t\t\t\n<style>\n#col-2005019896 > .col-inner {\n  margin: 0px 0px -20px 0px;\n}\n<\/style>\n\t<\/div>\n\n\t\n\n\t<div id=\"col-1534315974\" class=\"col small-12 large-12\"  >\n\t\t\t\t<div class=\"col-inner\"  >\n\t\t\t\n\t\t\t\n<h4>\u00bfEs necesaria la inclusi\u00f3n de ARTG para el software de dispositivos m\u00e9dicos basado en IA?<\/h4>\n\t<div id=\"gap-2072479767\" class=\"gap-element clearfix\" style=\"display:block; height:auto;\">\n\t\t\n<style>\n#gap-2072479767 {\n  padding-top: 10px;\n}\n<\/style>\n\t<\/div>\n\t\n<p>S\u00ed. El software habilitado con IA destinado al diagn\u00f3stico, monitoreo o tratamiento debe estar incluido en el <strong>ARTG antes del suministro<\/strong> en Australia.<\/p>\n\t\t<\/div>\n\t\t\t\t\n<style>\n#col-1534315974 > .col-inner {\n  margin: 0px 0px -20px 0px;\n}\n<\/style>\n\t<\/div>\n\n\t\n\n\t<div id=\"col-204465458\" class=\"col small-12 large-12\"  >\n\t\t\t\t<div class=\"col-inner\"  >\n\t\t\t\n\t\t\t\n<h4>\u00bfPueden los datos sint\u00e9ticos sustituir a la evidencia cl\u00ednica seg\u00fan las directrices actualizadas?<\/h4>\n\t<div id=\"gap-1685192170\" class=\"gap-element clearfix\" style=\"display:block; height:auto;\">\n\t\t\n<style>\n#gap-1685192170 {\n  padding-top: 10px;\n}\n<\/style>\n\t<\/div>\n\t\n<p>No. Los datos sint\u00e9ticos pueden <strong>complementan pero no reemplazan la evidencia cl\u00ednica,<\/strong> y su uso debe estar justificado y documentado.<\/p>\n\t\t<\/div>\n\t\t\t\t\n<style>\n#col-204465458 > .col-inner {\n  margin: 0px 0px -20px 0px;\n}\n<\/style>\n\t<\/div>\n\n\t\n\n\t<div id=\"col-513512581\" class=\"col small-12 large-12\"  >\n\t\t\t\t<div class=\"col-inner\"  >\n\t\t\t\n\t\t\t\n<h4>\u00bfC\u00f3mo puede RegASK ayudar a los equipos que gestionan el cumplimiento normativo de los dispositivos m\u00e9dicos con inteligencia artificial?<\/h4>\n\t<div id=\"gap-390536128\" class=\"gap-element clearfix\" style=\"display:block; height:auto;\">\n\t\t\n<style>\n#gap-390536128 {\n  padding-top: 10px;\n}\n<\/style>\n\t<\/div>\n\t\n<p><a href=\"http:\/\/regask.com\/es\/\"><strong>RegASK<\/strong><\/a> ayuda a las organizaciones a realizar un seguimiento de actualizaciones regulatorias como esta gu\u00eda de TGA, evaluar el impacto en las carteras de productos y coordinar respuestas de cumplimiento utilizando informaci\u00f3n impulsada por IA combinada con supervisi\u00f3n regulatoria experta.<\/p>\n\t\t<\/div>\n\t\t\t\t\n<style>\n#col-513512581 > .col-inner {\n  margin: 0px 0px -20px 0px;\n}\n<\/style>\n\t<\/div>\n\n\t\n<\/div>","protected":false},"excerpt":{"rendered":"<p>El 5 de febrero de 2026, la Administraci\u00f3n de Productos Terap\u00e9uticos (TGA, por sus siglas en ingl\u00e9s) public\u00f3 una gu\u00eda actualizada que aclara c\u00f3mo se regula el software con inteligencia artificial como dispositivo m\u00e9dico en Australia. Esta actualizaci\u00f3n afecta a las organizaciones que desarrollan, suministran o mantienen software para dispositivos m\u00e9dicos basado en IA y establece expectativas m\u00e1s claras en cuanto a la clasificaci\u00f3n regulatoria, la generaci\u00f3n de evidencia y la gesti\u00f3n del ciclo de vida.<\/p>","protected":false},"author":43,"featured_media":9493,"comment_status":"closed","ping_status":"closed","sticky":false,"template":"","format":"standard","meta":{"_acf_changed":false,"footnotes":""},"categories":[33,511,39],"tags":[],"class_list":["post-9492","post","type-post","status-publish","format-standard","has-post-thumbnail","hentry","category-news","category-australia-regulations","category-medical-devices-insights"],"acf":[],"yoast_head":"<!-- This site is optimized with the Yoast SEO Premium plugin v28.5 (Yoast SEO v28.6) - https:\/\/yoast.com\/product\/yoast-seo-premium-wordpress\/ -->\n<title>Australia TGA Updates Guidance on AI-Enabled Devices<\/title>\n<meta name=\"description\" content=\"Australia TGA updates guidance on AI-enabled medical device software, clarifying ARTG evidence requirements for manufacturers.\" \/>\n<meta name=\"robots\" content=\"index, follow, max-snippet:-1, max-image-preview:large, max-video-preview:-1\" \/>\n<link rel=\"canonical\" href=\"https:\/\/regask.com\/es\/la-tga-de-australia-actualiza-la-guia-sobre-software-de-dispositivos-medicos-con-ia-y-los-requisitos-de-evidencia-de-artg\/\" \/>\n<meta property=\"og:locale\" content=\"es_ES\" \/>\n<meta property=\"og:type\" content=\"article\" \/>\n<meta property=\"og:title\" content=\"Australia TGA Updates Guidance on AI-Enabled Medical Device Software and ARTG Evidence Requirements\" \/>\n<meta property=\"og:description\" content=\"Australia TGA updates guidance on AI-enabled medical device software, clarifying ARTG evidence requirements for manufacturers.\" \/>\n<meta property=\"og:url\" content=\"https:\/\/regask.com\/es\/la-tga-de-australia-actualiza-la-guia-sobre-software-de-dispositivos-medicos-con-ia-y-los-requisitos-de-evidencia-de-artg\/\" \/>\n<meta property=\"og:site_name\" content=\"RegASK\" \/>\n<meta property=\"article:publisher\" content=\"https:\/\/www.facebook.com\/RegASKRegulatoryAffairs\/\" \/>\n<meta property=\"article:published_time\" content=\"2026-02-16T09:31:59+00:00\" \/>\n<meta property=\"og:image\" content=\"https:\/\/regask.com\/wp-content\/uploads\/2026\/02\/australia-tga-updates-guidance-ai-enabled-medical-device-software-artg-evidence-requirements.png\" \/>\n\t<meta property=\"og:image:width\" content=\"904\" \/>\n\t<meta property=\"og:image:height\" content=\"622\" \/>\n\t<meta property=\"og:image:type\" content=\"image\/png\" \/>\n<meta name=\"author\" content=\"Reva Ananda\" \/>\n<meta name=\"twitter:card\" content=\"summary_large_image\" \/>\n<meta name=\"twitter:creator\" content=\"@ASKRegASK\" \/>\n<meta name=\"twitter:site\" content=\"@ASKRegASK\" \/>\n<meta name=\"twitter:label1\" content=\"Written by\" \/>\n\t<meta name=\"twitter:data1\" content=\"Reva Ananda\" \/>\n\t<meta name=\"twitter:label2\" content=\"Est. reading time\" \/>\n\t<meta name=\"twitter:data2\" content=\"4 minutos\" \/>\n<script type=\"application\/ld+json\" class=\"yoast-schema-graph\">{\"@context\":\"https:\\\/\\\/schema.org\",\"@graph\":[{\"@type\":\"Article\",\"@id\":\"https:\\\/\\\/regask.com\\\/australia-tga-updates-guidance-on-ai-enabled-medical-device-software-and-artg-evidence-requirements\\\/#article\",\"isPartOf\":{\"@id\":\"https:\\\/\\\/regask.com\\\/australia-tga-updates-guidance-on-ai-enabled-medical-device-software-and-artg-evidence-requirements\\\/\"},\"author\":{\"name\":\"Reva Ananda\",\"@id\":\"https:\\\/\\\/regask.com\\\/#\\\/schema\\\/person\\\/4023a3aab44f61a84d06ca8abfcbe926\"},\"headline\":\"Australia TGA Updates Guidance on AI-Enabled Medical De&hellip;\",\"datePublished\":\"2026-02-16T09:31:59+00:00\",\"mainEntityOfPage\":{\"@id\":\"https:\\\/\\\/regask.com\\\/australia-tga-updates-guidance-on-ai-enabled-medical-device-software-and-artg-evidence-requirements\\\/\"},\"wordCount\":776,\"publisher\":{\"@id\":\"https:\\\/\\\/regask.com\\\/#organization\"},\"image\":{\"@id\":\"https:\\\/\\\/regask.com\\\/australia-tga-updates-guidance-on-ai-enabled-medical-device-software-and-artg-evidence-requirements\\\/#primaryimage\"},\"thumbnailUrl\":\"https:\\\/\\\/regask.com\\\/wp-content\\\/uploads\\\/2026\\\/02\\\/australia-tga-updates-guidance-ai-enabled-medical-device-software-artg-evidence-requirements.png\",\"articleSection\":[\"Regulatory News\",\"Australia\",\"Medical Devices\"],\"inLanguage\":\"es\"},{\"@type\":\"WebPage\",\"@id\":\"https:\\\/\\\/regask.com\\\/australia-tga-updates-guidance-on-ai-enabled-medical-device-software-and-artg-evidence-requirements\\\/\",\"url\":\"https:\\\/\\\/regask.com\\\/australia-tga-updates-guidance-on-ai-enabled-medical-device-software-and-artg-evidence-requirements\\\/\",\"name\":\"Australia TGA Updates Guidance on AI-Enabled Devices\",\"isPartOf\":{\"@id\":\"https:\\\/\\\/regask.com\\\/#website\"},\"primaryImageOfPage\":{\"@id\":\"https:\\\/\\\/regask.com\\\/australia-tga-updates-guidance-on-ai-enabled-medical-device-software-and-artg-evidence-requirements\\\/#primaryimage\"},\"image\":{\"@id\":\"https:\\\/\\\/regask.com\\\/australia-tga-updates-guidance-on-ai-enabled-medical-device-software-and-artg-evidence-requirements\\\/#primaryimage\"},\"thumbnailUrl\":\"https:\\\/\\\/regask.com\\\/wp-content\\\/uploads\\\/2026\\\/02\\\/australia-tga-updates-guidance-ai-enabled-medical-device-software-artg-evidence-requirements.png\",\"datePublished\":\"2026-02-16T09:31:59+00:00\",\"description\":\"Australia TGA updates guidance on AI-enabled medical device software, clarifying ARTG evidence requirements for manufacturers.\",\"inLanguage\":\"es\",\"potentialAction\":[{\"@type\":\"ReadAction\",\"target\":[\"https:\\\/\\\/regask.com\\\/australia-tga-updates-guidance-on-ai-enabled-medical-device-software-and-artg-evidence-requirements\\\/\"]}]},{\"@type\":\"ImageObject\",\"inLanguage\":\"es\",\"@id\":\"https:\\\/\\\/regask.com\\\/australia-tga-updates-guidance-on-ai-enabled-medical-device-software-and-artg-evidence-requirements\\\/#primaryimage\",\"url\":\"https:\\\/\\\/regask.com\\\/wp-content\\\/uploads\\\/2026\\\/02\\\/australia-tga-updates-guidance-ai-enabled-medical-device-software-artg-evidence-requirements.png\",\"contentUrl\":\"https:\\\/\\\/regask.com\\\/wp-content\\\/uploads\\\/2026\\\/02\\\/australia-tga-updates-guidance-ai-enabled-medical-device-software-artg-evidence-requirements.png\",\"width\":904,\"height\":622,\"caption\":\"Australia Tga Updates Guidance Ai Enabled Medical Device Software Artg Evidence Requirements\"},{\"@type\":\"WebSite\",\"@id\":\"https:\\\/\\\/regask.com\\\/#website\",\"url\":\"https:\\\/\\\/regask.com\\\/\",\"name\":\"RegASK\",\"description\":\"The Regulatory AI Operating System for High-Performing Teams\",\"publisher\":{\"@id\":\"https:\\\/\\\/regask.com\\\/#organization\"},\"potentialAction\":[{\"@type\":\"SearchAction\",\"target\":{\"@type\":\"EntryPoint\",\"urlTemplate\":\"https:\\\/\\\/regask.com\\\/?s={search_term_string}\"},\"query-input\":{\"@type\":\"PropertyValueSpecification\",\"valueRequired\":true,\"valueName\":\"search_term_string\"}}],\"inLanguage\":\"es\"},{\"@type\":\"Organization\",\"@id\":\"https:\\\/\\\/regask.com\\\/#organization\",\"name\":\"RegASK\",\"url\":\"https:\\\/\\\/regask.com\\\/\",\"logo\":{\"@type\":\"ImageObject\",\"inLanguage\":\"es\",\"@id\":\"https:\\\/\\\/regask.com\\\/#\\\/schema\\\/logo\\\/image\\\/\",\"url\":\"https:\\\/\\\/regask.com\\\/wp-content\\\/uploads\\\/2024\\\/10\\\/RegASK-Logo-Dark-Round.png\",\"contentUrl\":\"https:\\\/\\\/regask.com\\\/wp-content\\\/uploads\\\/2024\\\/10\\\/RegASK-Logo-Dark-Round.png\",\"width\":401,\"height\":401,\"caption\":\"RegASK\"},\"image\":{\"@id\":\"https:\\\/\\\/regask.com\\\/#\\\/schema\\\/logo\\\/image\\\/\"},\"sameAs\":[\"https:\\\/\\\/www.facebook.com\\\/RegASKRegulatoryAffairs\\\/\",\"https:\\\/\\\/x.com\\\/ASKRegASK\",\"https:\\\/\\\/www.linkedin.com\\\/company\\\/RegASK\\\/\",\"https:\\\/\\\/www.youtube.com\\\/@RegASK\",\"https:\\\/\\\/www.crunchbase.com\\\/organization\\\/regask\",\"https:\\\/\\\/www.bloomberg.com\\\/profile\\\/company\\\/1691237D:SP\",\"https:\\\/\\\/pitchbook.com\\\/profiles\\\/company\\\/265004-02\",\"https:\\\/\\\/www.cbinsights.com\\\/company\\\/RegASK\",\"https:\\\/\\\/vimeo.com\\\/RegASK\"],\"legalName\":\"RegASK PTE. LTD.\",\"foundingDate\":\"2018\",\"slogan\":\"Empowering Smarter Regulatory Decisions\",\"description\":\"Agentic AI regulatory intelligence and workflow orchestration platform for Life Sciences and Consumer Products. RegASK combines vertical LLMs, multi-agent AI architecture, and a global community of 1,800+ subject matter experts to deliver regulatory horizon scanning, impact analysis, compliance workflow automation, and audit-ready outputs across 160+ countries.\",\"areaServed\":\"Worldwide\",\"founder\":{\"@type\":\"Person\",\"name\":\"Caroline Shleifer\",\"jobTitle\":\"Founder & CEO\"},\"address\":{\"@type\":\"PostalAddress\",\"streetAddress\":\"79 Science Park Drive, #06-01, Cintech IV\",\"addressLocality\":\"Singapore\",\"postalCode\":\"118264\",\"addressCountry\":\"SG\"},\"contactPoint\":{\"@type\":\"ContactPoint\",\"telephone\":\"+65 6817 6290\",\"contactType\":\"customer service\",\"availableLanguage\":[\"English\",\"French\",\"Japanese\",\"Spanish\",\"Chinese\",\"German\"]},\"numberOfEmployees\":{\"@type\":\"QuantitativeValue\",\"minValue\":50,\"maxValue\":100},\"knowsAbout\":[\"Regulatory Intelligence\",\"Regulatory Compliance\",\"Regulatory Affairs\",\"Workflow Orchestration\",\"Life Sciences Regulation\",\"Consumer Products Regulation\",\"AI-Driven Compliance\"],\"hasCertification\":[{\"@type\":\"Certification\",\"name\":\"ISO\\\/IEC 42001:2023\"},{\"@type\":\"Certification\",\"name\":\"ISO\\\/IEC 27001:2022\"},{\"@type\":\"Certification\",\"name\":\"ISO\\\/IEC 27701\"},{\"@type\":\"Certification\",\"name\":\"ISO\\\/IEC 27018:2019\"},{\"@type\":\"Certification\",\"name\":\"SOC 2 Type II\"}]},{\"@type\":\"Person\",\"@id\":\"https:\\\/\\\/regask.com\\\/#\\\/schema\\\/person\\\/4023a3aab44f61a84d06ca8abfcbe926\",\"name\":\"Reva Ananda\"}]}<\/script>\n<!-- \/ Yoast SEO Premium plugin. -->","yoast_head_json":{"title":"La TGA de Australia actualiza la gu\u00eda sobre dispositivos con inteligencia artificial","description":"La TGA de Australia actualiza la gu\u00eda sobre el software de dispositivos m\u00e9dicos habilitado con IA, aclarando los requisitos de evidencia de ARTG para los fabricantes.","robots":{"index":"index","follow":"follow","max-snippet":"max-snippet:-1","max-image-preview":"max-image-preview:large","max-video-preview":"max-video-preview:-1"},"canonical":"https:\/\/regask.com\/es\/la-tga-de-australia-actualiza-la-guia-sobre-software-de-dispositivos-medicos-con-ia-y-los-requisitos-de-evidencia-de-artg\/","og_locale":"es_ES","og_type":"article","og_title":"Australia TGA Updates Guidance on AI-Enabled Medical Device Software and ARTG Evidence Requirements","og_description":"Australia TGA updates guidance on AI-enabled medical device software, clarifying ARTG evidence requirements for manufacturers.","og_url":"https:\/\/regask.com\/es\/la-tga-de-australia-actualiza-la-guia-sobre-software-de-dispositivos-medicos-con-ia-y-los-requisitos-de-evidencia-de-artg\/","og_site_name":"RegASK","article_publisher":"https:\/\/www.facebook.com\/RegASKRegulatoryAffairs\/","article_published_time":"2026-02-16T09:31:59+00:00","og_image":[{"width":904,"height":622,"url":"https:\/\/regask.com\/wp-content\/uploads\/2026\/02\/australia-tga-updates-guidance-ai-enabled-medical-device-software-artg-evidence-requirements.png","type":"image\/png"}],"author":"Reva Ananda","twitter_card":"summary_large_image","twitter_creator":"@ASKRegASK","twitter_site":"@ASKRegASK","twitter_misc":{"Written by":"Reva Ananda","Est. reading time":"4 minutos"},"schema":{"@context":"https:\/\/schema.org","@graph":[{"@type":"Article","@id":"https:\/\/regask.com\/australia-tga-updates-guidance-on-ai-enabled-medical-device-software-and-artg-evidence-requirements\/#article","isPartOf":{"@id":"https:\/\/regask.com\/australia-tga-updates-guidance-on-ai-enabled-medical-device-software-and-artg-evidence-requirements\/"},"author":{"name":"Reva Ananda","@id":"https:\/\/regask.com\/#\/schema\/person\/4023a3aab44f61a84d06ca8abfcbe926"},"headline":"Australia TGA Updates Guidance on AI-Enabled Medical De&hellip;","datePublished":"2026-02-16T09:31:59+00:00","mainEntityOfPage":{"@id":"https:\/\/regask.com\/australia-tga-updates-guidance-on-ai-enabled-medical-device-software-and-artg-evidence-requirements\/"},"wordCount":776,"publisher":{"@id":"https:\/\/regask.com\/#organization"},"image":{"@id":"https:\/\/regask.com\/australia-tga-updates-guidance-on-ai-enabled-medical-device-software-and-artg-evidence-requirements\/#primaryimage"},"thumbnailUrl":"https:\/\/regask.com\/wp-content\/uploads\/2026\/02\/australia-tga-updates-guidance-ai-enabled-medical-device-software-artg-evidence-requirements.png","articleSection":["Regulatory News","Australia","Medical Devices"],"inLanguage":"es"},{"@type":"WebPage","@id":"https:\/\/regask.com\/australia-tga-updates-guidance-on-ai-enabled-medical-device-software-and-artg-evidence-requirements\/","url":"https:\/\/regask.com\/australia-tga-updates-guidance-on-ai-enabled-medical-device-software-and-artg-evidence-requirements\/","name":"La TGA de Australia actualiza la gu\u00eda sobre dispositivos con inteligencia artificial","isPartOf":{"@id":"https:\/\/regask.com\/#website"},"primaryImageOfPage":{"@id":"https:\/\/regask.com\/australia-tga-updates-guidance-on-ai-enabled-medical-device-software-and-artg-evidence-requirements\/#primaryimage"},"image":{"@id":"https:\/\/regask.com\/australia-tga-updates-guidance-on-ai-enabled-medical-device-software-and-artg-evidence-requirements\/#primaryimage"},"thumbnailUrl":"https:\/\/regask.com\/wp-content\/uploads\/2026\/02\/australia-tga-updates-guidance-ai-enabled-medical-device-software-artg-evidence-requirements.png","datePublished":"2026-02-16T09:31:59+00:00","description":"La TGA de Australia actualiza la gu\u00eda sobre el software de dispositivos m\u00e9dicos habilitado con IA, aclarando los requisitos de evidencia de ARTG para los fabricantes.","inLanguage":"es","potentialAction":[{"@type":"ReadAction","target":["https:\/\/regask.com\/australia-tga-updates-guidance-on-ai-enabled-medical-device-software-and-artg-evidence-requirements\/"]}]},{"@type":"ImageObject","inLanguage":"es","@id":"https:\/\/regask.com\/australia-tga-updates-guidance-on-ai-enabled-medical-device-software-and-artg-evidence-requirements\/#primaryimage","url":"https:\/\/regask.com\/wp-content\/uploads\/2026\/02\/australia-tga-updates-guidance-ai-enabled-medical-device-software-artg-evidence-requirements.png","contentUrl":"https:\/\/regask.com\/wp-content\/uploads\/2026\/02\/australia-tga-updates-guidance-ai-enabled-medical-device-software-artg-evidence-requirements.png","width":904,"height":622,"caption":"Australia Tga Updates Guidance Ai Enabled Medical Device Software Artg Evidence Requirements"},{"@type":"WebSite","@id":"https:\/\/regask.com\/#website","url":"https:\/\/regask.com\/","name":"RegASK","description":"El sistema operativo de IA regulatoria para equipos de alto rendimiento","publisher":{"@id":"https:\/\/regask.com\/#organization"},"potentialAction":[{"@type":"SearchAction","target":{"@type":"EntryPoint","urlTemplate":"https:\/\/regask.com\/?s={search_term_string}"},"query-input":{"@type":"PropertyValueSpecification","valueRequired":true,"valueName":"search_term_string"}}],"inLanguage":"es"},{"@type":"Organization","@id":"https:\/\/regask.com\/#organization","name":"RegASK","url":"https:\/\/regask.com\/","logo":{"@type":"ImageObject","inLanguage":"es","@id":"https:\/\/regask.com\/#\/schema\/logo\/image\/","url":"https:\/\/regask.com\/wp-content\/uploads\/2024\/10\/RegASK-Logo-Dark-Round.png","contentUrl":"https:\/\/regask.com\/wp-content\/uploads\/2024\/10\/RegASK-Logo-Dark-Round.png","width":401,"height":401,"caption":"RegASK"},"image":{"@id":"https:\/\/regask.com\/#\/schema\/logo\/image\/"},"sameAs":["https:\/\/www.facebook.com\/RegASKRegulatoryAffairs\/","https:\/\/x.com\/ASKRegASK","https:\/\/www.linkedin.com\/company\/RegASK\/","https:\/\/www.youtube.com\/@RegASK","https:\/\/www.crunchbase.com\/organization\/regask","https:\/\/www.bloomberg.com\/profile\/company\/1691237D:SP","https:\/\/pitchbook.com\/profiles\/company\/265004-02","https:\/\/www.cbinsights.com\/company\/RegASK","https:\/\/vimeo.com\/RegASK"],"legalName":"RegASK PTE. LTD.","foundingDate":"2018","slogan":"Empowering Smarter Regulatory Decisions","description":"Plataforma de inteligencia regulatoria y orquestaci\u00f3n de flujos de trabajo con IA para ciencias de la vida y productos de consumo. RegASK combina modelos de negocio verticales, arquitectura de IA multiagente y una comunidad global de m\u00e1s de 1800 expertos para ofrecer an\u00e1lisis de horizontes regulatorios, an\u00e1lisis de impacto, automatizaci\u00f3n de flujos de trabajo de cumplimiento y resultados listos para auditor\u00edas en m\u00e1s de 160 pa\u00edses.","areaServed":"Worldwide","founder":{"@type":"Person","name":"Caroline Shleifer","jobTitle":"Founder & CEO"},"address":{"@type":"PostalAddress","streetAddress":"79 Science Park Drive, #06-01, Cintech IV","addressLocality":"Singapore","postalCode":"118264","addressCountry":"SG"},"contactPoint":{"@type":"ContactPoint","telephone":"+65 6817 6290","contactType":"customer service","availableLanguage":["English","French","Japanese","Spanish","Chinese","German"]},"numberOfEmployees":{"@type":"QuantitativeValue","minValue":50,"maxValue":100},"knowsAbout":["Regulatory Intelligence","Regulatory Compliance","Regulatory Affairs","Workflow Orchestration","Life Sciences Regulation","Consumer Products Regulation","AI-Driven Compliance"],"hasCertification":[{"@type":"Certification","name":"ISO\/IEC 42001:2023"},{"@type":"Certification","name":"ISO\/IEC 27001:2022"},{"@type":"Certification","name":"ISO\/IEC 27701"},{"@type":"Certification","name":"ISO\/IEC 27018:2019"},{"@type":"Certification","name":"SOC 2 Type II"}]},{"@type":"Person","@id":"https:\/\/regask.com\/#\/schema\/person\/4023a3aab44f61a84d06ca8abfcbe926","name":"Reva Ananda"}]}},"_links":{"self":[{"href":"https:\/\/regask.com\/es\/wp-json\/wp\/v2\/posts\/9492","targetHints":{"allow":["GET"]}}],"collection":[{"href":"https:\/\/regask.com\/es\/wp-json\/wp\/v2\/posts"}],"about":[{"href":"https:\/\/regask.com\/es\/wp-json\/wp\/v2\/types\/post"}],"author":[{"embeddable":true,"href":"https:\/\/regask.com\/es\/wp-json\/wp\/v2\/users\/43"}],"replies":[{"embeddable":true,"href":"https:\/\/regask.com\/es\/wp-json\/wp\/v2\/comments?post=9492"}],"version-history":[{"count":0,"href":"https:\/\/regask.com\/es\/wp-json\/wp\/v2\/posts\/9492\/revisions"}],"wp:featuredmedia":[{"embeddable":true,"href":"https:\/\/regask.com\/es\/wp-json\/wp\/v2\/media\/9493"}],"wp:attachment":[{"href":"https:\/\/regask.com\/es\/wp-json\/wp\/v2\/media?parent=9492"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/regask.com\/es\/wp-json\/wp\/v2\/categories?post=9492"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/regask.com\/es\/wp-json\/wp\/v2\/tags?post=9492"}],"curies":[{"name":"Gracias","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}